Natural History of Coronary Atherosclerosis

NCT06040073 | Recruiting

• 1 other identifier: 2023-GSP-GG-3
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The present study sought to explore the predictive value of radial wall strain (RWS, derived solely from angiograms) for coronary artery lesion progression compared with lesion vulnerability assessed by optical coherence tomography (OCT). The lesion progression at 1 year was defined as an increase of ≥20% in diameter stenosis based on quantitative coronary angiography (QCA) evaluation.

Conditions

Coronary Artery Disease Progression; Radial Wall Strain; Atherosclerotic Lesion; Optical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

• Lesion progression assessed by QCA

  Defined as an increase of ≥20% in diameter stenosis based on QCA evaluation

  1 year

Secondary Outcomes (13)

• Incidence of major adverse cardiac events (MACE)

  1 year, 2 years, 3 years

• Incidence of all-cause death

  1 year, 2 years, 3 years

• Incidence of new myocardial infarction

  1 year, 2 years, 3 years

• Incidence of unplanned revascularization

  1 year, 2 years, 3 years

• Incidence of stent thrombosis

  1 year, 2 years, 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult study participants with acute myocardial infarction complicated by multi-vessel coronary artery diseases within 45 days.

You may qualify if:

• Age ≥18 years
• Acute myocardial infarction ≤ 45 days
• Planned coronary angiography examination or potential interventional treatment
• The presence of at least 1 non-flow-restricting lesion (visually estimated diameter stenosis: 30%-80%; QFR \> 0.80) in any non-infarct related artery with RVD ≥2.5 mm by visual assessment

You may not qualify if:

• Cardiogenic shock
• Pregnant or woman of child-bearing potential
• Life expectancy less than 1 year for non-cardiac causes
• Unable to tolerate contrast agents or anticoagulant/antiplatelet therapy
• Prior CABG or planned CABG
• Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification, branch ostium cannot be shown clearly, severe overlap in the stenosed segment or severe tortuosity of any interrogated vessel deemed not amenable to QFR or RWS measurement
• An interrogated lesion require surgical bypass grafting
• Unable to judge culprit lesion or infarct-related artery according to current evidence

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Lei Song

Beijing, 100037, China

RECRUITING

Related Publications (1)

• Jiang Y, Sun Z, Yu B, Liu W, Gao H, Li J, Jin Z, Yu H, Zheng B, Guan C, Zhang H, Zhang Y, Gao L, Cui C, Song Y, Xu J, Dou K, Yang W, Qian J, Wu Y, Song L. Natural history of coronary atherosclerosis based on multimodal imaging and physiological fusion techniques: study protocol and rationale for the NASCENT study. BMJ Open. 2025 Oct 23;15(10):e105796. doi: 10.1136/bmjopen-2025-105796.

  PMID: 41130689 DERIVED

Study Officials

• Lei Song, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Song, MD

CONTACT

01088322564; drsong@vip.163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Coronary Heart Disease Ward, First Section

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: September 15, 2023
• Study Start: July 7, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

CN (1)